Biostatistics and Data Management

Adaptive Trials. Technology and techniques for agile clinical trial design.

Traditional sequential clinical trial designs are expensive and time-consuming. Using statistical means to employ accumulating data to inform and modify trial designs can lead to an increase in flexibility and efficiency.

ARG has experience using sample size re-estimation, seamless phase transitions, predictive analytics, Bayesian statistics, and many other adaptive trial techniques to introduce planned modifications based on quantitative analysis of trial data.

The quality and integrity of data is vital to any clinical trial. That’s why ARG’s data management team is committed to the delivery of accurate data management solutions that are customizable to each client’s requirements. Our solutions are cost effective, secure, compliant and expedite the data collection process. Our Data Management team is involved from the start of the project with data management plan and CRF development through the coding and evaluation and analysis of incoming data. Our data management team is experienced with a variety of systems including SAS, Oracle and Clintrial systems. ARG utilizes OpenClinica Enterprise, a powerful yet intuitive CDISC compliant Electronic Data Capture (EDC) system that can also manage paper-based and hybrid (eCRF + paper CRF) trials.

Our biostatistics team has experience working with a variety of platforms to meet each clients needs. ARG provides experienced staff to evaluate, organize and present trial information in a timely manner. We are capable of providing full service biostatistical analysis or isolated components such as protocol development, strategic consulting, or quality control and analysis.